BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANAT BRG RT SM SIZE 3 PMA

    MDR report key: 23851603 · Received December 19, 2025

    Report

    Report Number
    3002806535-2025-00655
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 22, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786145
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: OXFORD PH3 CEMENTLESS FEM SZ S; ITEM# 154925; LOT# 6286792. OXF UNI CMNTLS TIB SZ B RM; ITEM# 166573; LOT# 6232854. G2 - FOREIGN: EVENT OCCURRED IN CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SIX YEARS AND NINE MONTHS AFTER THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A FRACTURED BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256459 OXFORD ANAT BRG RT SM SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. 6408408 05019279786145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.